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Electronic records and signature requirements

The use of electronic medical records and electronic handling of study data is common practice in research and is commonly assessed by study sponsors and CROs. To successfully utilize computer systems in clinical research requires a working knowledge of the basic requirements of 21 CFR Part 11 (Electronic records; Electronic signatures) compliance. 

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NIH funding update

Some good news for all and very good news for early-stage and mid-career Investigators.

Undoubtedly everyone involved in any facet of biomedical research is aware that the current funding climate is difficult. The NIH budget, although increased incrementally by Congress, has been unable to keep pace with inflation. 

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